Jubilant Pharmova announced that its subsidiary, Jubilant Generics, has received a tentative approval from the US Food and Drug Administration (USFDA) for Pantoprazole Sodium delayed release oral suspension, 40 mg per packet. According to reports from CNBC TV18, the drug is primarily used to treat gastroesophageal reflux disease (GERD) and heal acid-related damage to the esophagus. The tentative approval is subject to the expiry of the patent covering the currently listed Reference Listed Drug (RLD), which is expected to occur in December 2026. The disclosure was made to stock exchanges under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, with the company confirming receipt of the information on June 25, 2026, at 11:47 am.
The approval follows successful completion of the pre-approval inspection (PAI) conducted by the USFDA at the solid dosage manufacturing facility located at Roorkee, Uttarakhand. As reported by CNBC TV18, Jubilant Generics is a subsidiary of Jubilant Pharma, which is a wholly owned subsidiary of the company. The latest development underscores the company's continued progress in expanding its U.S. generics portfolio, with the approval following a pre-approval inspection completed in 2025. Final approval is anticipated upon such patent expiry, providing clarity on the commercial timeline for this product. The development positions the company to enter the US market upon the expiry of the relevant patent.
Jubilant Pharmova reported consolidated net profit of ₹119 crore for Q4 FY26, marking a 23% year-over-year decrease from ₹154 crore during the same period in the previous year, as per CNBC TV18. The company's EBITDA margin fell dramatically to 14.8% from 17.9% due to increased operational costs and pressure on profitability, while EBITDA dipped slightly by 1.6% to ₹339.3 crore from ₹345 crore a year ago. The stock closed at ₹964.40 on Thursday, 25th June 2026, declining 0.84% and showing a decline of over 10% in the past 6 months.
This development strengthens the company's pipeline in the gastrointestinal therapy segment and could enhance its revenue prospects and competitive standing in the U.S. generics market once commercialization begins. As reported by TipRanks, the company operates through subsidiaries such as Jubilant Pharma Limited and Jubilant Generics Limited, focusing on generic formulations and specialized dosage forms for global markets, including the U.S.. The company manufactures solid dosage products at its Roorkee facility, which is subject to regulatory oversight by agencies such as the USFDA.
